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Abstral Approval History

  • FDA approved: Yes (First approved January 7th, 2011)
  • Brand name: Abstral
  • Generic name: fentanyl
  • Dosage form: Sublingual Tablets
  • Company: Orexo AB
  • Treatment for: Pain

Abstral (fentanyl) is a sublingual opioid analgesic indicated for the management of breakthrough pain in cancer patients.

Development History and FDA Approval Process for Abstral

Jan 10, 2011Approval FDA Approval for Abstral (Fentanyl) Sublingual Tablets
Sep  7, 2010Update on the FDA review for Abstral
Jun 15, 2010Orexo confirms Abstral PDUFA date update
Oct  6, 2009Orexo confirms FDA acceptance of Abstral filing
Aug  6, 2009Abstral NDA submitted to the FDA for approval in the USA

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